MedDataX Logo

Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients

NCT ID: NCT00644020

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.
* Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.
* Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.
* A CT scan or MRI scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hepatocellular carcinoma recurrence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

the Tyroserleutide for injection at the dosage of 3mg/d

mitomycin, Fluorouracil

Intervention Type DRUG

All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.

Group 2

the Tyroserleutide for injection at the dosage of 6mg/d

mitomycin, Fluorouracil

Intervention Type DRUG

All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.

Group 3

the Tyroserleutide for injection at the dosage of 12mg/d

mitomycin, Fluorouracil

Intervention Type DRUG

All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.

Group 4

the placebo group

mitomycin, Fluorouracil

Intervention Type DRUG

All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mitomycin, Fluorouracil

All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

mitomycin: serial numbers:071006 Fluorouracil: serial numbers:0710071

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Written informed consent
2. Age between 18 and 75 years
3. Hepatocellular Carcinoma accompanied with branch vein thrombosis
4. Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
5. CTA or MRI no Carcinoma and bolt after operation

Exclusion Criteria

1. hypersensitivity to the composition similarity of investigational drug
2. Concomitance other system primary tumor
3. surface area 1.47m2～1.92m2
4. HBV (-) and HCV(-)
5. Patients who have received resectional surgery for HCC
6. HCC complicating main portal vein cork
7. HCC complicating hepatic vein cork
8. Patients who have received systematicness therapy for HCC
9. Patients who have received immunoregulant 4 weeks before randomization
10. Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
11. uncontrolled infection, hemorrhage, guts leakage postoperative complications
12. postoperative liver function Child-pugh C
13. no evidence of extra-hepatic metastases postoperative
14. no utility sample for gene chip research
15. no physical examination, laboratory and imageology examination that baseline request
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tongji Hospital of Tongji Medical College of HUST

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chen X P, Professor

Role: PRINCIPAL_INVESTIGATOR

Tongji Medical College of Huazhong University of ScienceTechnology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

A Research Institute of Tumor

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chen X P, professor

Role: CONTACT

Phone: 027-83662599

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Weihua Jia, Professor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TYS-CN-1.1PUMPⅡPartA

Identifier Type: -

Identifier Source: secondary_id

TYS-CN-1.1PUMPⅡPartA

Identifier Type: -

Identifier Source: org_study_id